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features
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support

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Description

SimpleTrials is a subscription-driven, on-demand Clinical Trial Management System (CTMS) tailored for sponsors, Contract Research Organizations (CROs), and research sites. It encompasses a wide array of tools designed to efficiently plan, oversee, and monitor clinical study portfolios, featuring capabilities such as site initiation and subject monitoring, document management through an integrated electronic Trial Master File (eTMF), real-time analytics for studies, comprehensive calendars and monitoring options, customizable fields and trackers, on-demand reporting, planning milestones, management of site contracts and payments, as well as electronic visit documentation. The platform is built to ensure compliance with 21 CFR Part 11 and establishes a secure, validated space for handling clinical trial data. Users benefit from the ability to personalize tracking views, connect with various Electronic Data Capture (EDC) systems, and access pre-built templates for uniform document management. Furthermore, the system enhances collaboration among stakeholders, facilitating smoother communication throughout the trial process.

Description

Enhance the efficiency of regulatory operations within your organization to bolster compliance and facilitate research advancements. Veeva SiteVault simplifies the process of managing clinical trials by integrating your regulatory tasks, leading to improved effectiveness and adherence to regulations. You can oversee regulatory and source documents through a unified platform that complies with 21 CFR Part 11 and HIPAA standards. With real-time insights across all trials, SiteVault Enterprise boosts operational effectiveness, accelerates study initiation, and fosters swift, high-quality trial management. Transition away from manual workflows and customize your own processes to enhance both quality and speed in study activation. By granting monitors secure, direct access to your regulatory and source documents, you eliminate the hassles of EMR access and document redaction. Furthermore, you can tailor your workflows, generate reports, and create dashboards to gain deeper insights into start-up timelines and regulatory workflows, ultimately driving better outcomes for your clinical trials. This comprehensive approach not only streamlines processes but also enhances collaboration across teams.

API Access

Has API Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Microsoft 365 No 
REDCap Yes 

Integrations

Microsoft 365 Yes 
REDCap No 

Pricing Details

$849 per month
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

SimpleTrials

Founded

2008

Country

United States

Website

www.simpletrials.com

Vendor Details

Company Name

Veeva Systems

Country

United States

Website

sites.veeva.com/products/sitevault-enterprise/

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Scientific Data Management System (SDMS)

Analytics No 
Artificial Intelligence (AI) No 
Audit No 
Centralized Data Repository No 
Collaboration No 
Compliance No 
Data Security No 
ELN Integration No 
LIMS Integration No 
Workflows No 

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